BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 14 MM HEIGHT

    MDR report key: 6182932 · Received December 16, 2016

    Report

    Report Number
    0001822565-2016-04710
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 3, 2013
    Report Date
    June 14, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    OIY
    PMA / PMN Number
    PK121771
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001822565-2016-03948-1, 0001822565-2016-04708, 0001822565-2016-04709, AND 0001822565-2016-04710).

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING LIMITED RANGE OF MOTION, LIMPING, PAIN, SWELLING, TIBIAL AND SHIN PAIN AND TIBIAL COMPONENT SUBSIDING. PATIENT WAS PRESCRIBED PHYSICAL THERAPY BUT WAS NON-COMPLIANT. NO REVISION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832352 ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 14 MM HEIGHT PROSTHESIS, KNEE OIY ZIMMER, INC. N/A 62277091

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other